A Prospective Open Label Clinical Trial to evaluate the response of Homoeopathic intervention in plantar fascitis including calcaneal spur
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- To evaluate the outcome of homoeopathic intervention on heel pain and functional ability in patients with plantar fasciitis as measured by the Visual Analogue Scale (VAS) and the Plantar Fasciitis Pain and Disability Scale (PFPS)
研究概览
简要总结
This is a prospective, open-label clinical trial to evaluate the response to homeopathic intervention in plantar fasciitis, including calcaneal spur, which will be conducted at the Dr. Anjali Chatterji Regional Research Institute for Homoeopathy in Kolkata. All participants aged 18 to 65 years who have symptoms of plantar fasciitis (with or without calcaneal spur) will be studied. As per the inclusion criteria, clinically and radiologically diagnosed cases of plantar fasciitis will be treated with Individualized homeopathic medicine in centesimal potencies manufactured by a licensed homeopathic pharmaceutical company approved by the Council. The duration of the study intervention is six months. The primary outcome measures shall be assessment of symptoms clinically and utilizing the Plantar fasciitis pain & disability scale (PFPS), including VAS at every 6 weeks up to 6 months. The secondary outcome measures shall assess the general wellbeing and QoL using ORDIL Scales at every 6 weeks for 6 months and compare the changes in Calcaneal spur and in the thickness of Plantar Fascia through assessment by Radiography and USG respectively at baseline and at the end of 6 months of treatment.
Upon completion of the study, data will be statistically analyzed (paired t-test and one-way repeated measures of ANOVA using appropriate statistical software (SPSS) to determine the usefulness of individualized homeopathy in managing symptoms of Plantar fasciitis and improving quality of life. The results are intended to be disseminated to the medical community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 years
- •Patients of both sexes
- •Diagnosed case of heel pain with plantar fascitis may be unilateral or bilateral
- •Pain in heel (unilateral or bilateral ) in the morning after waking up or first few steps after sitting down or rest for a long time,
- •Local pain and tenderness where the plantar fascia attaches to the heel,
- •Increasing pain in heel with extended walking or standing for more than 15 min.
- •Written Informed consent from the patient.
- •Wash-out period of at least two weeks for any ongoing conventional medicines.
排除标准
- •Subjects with diagnosed cases of advanced stage of Metabolic disorders like advanced-stage of Diabetes, CKD, and Cardiovascular diseases.
- •Subjects with Focal neurological diseases.
- •Subjects with impaired lower limb circulation.
- •Subjects with infectious diseases of the lower limb.
- •Subjects with congenital deformities of foot and ankle.
- •Subjects who are on other medications.
- •Pregnant and lactating mother.
- •Subjects not willing to participate in the study.
结局指标
主要结局
To evaluate the outcome of homoeopathic intervention on heel pain and functional ability in patients with plantar fasciitis as measured by the Visual Analogue Scale (VAS) and the Plantar Fasciitis Pain and Disability Scale (PFPS)
时间窗: every 6-week intervals for 6 months
次要结局
- 1. To evaluate the outcome of homoeopathic intervention on heel pain, general well-being, & quality of life (QoL) using the Outcome Related to Impact on Daily Living (ORDIL) scale(2. To assess the changes in plantar fascia thickness by ultrasonography & in calcaneal spur (if associated with plantar fasciitis) by digital radiography following homoeopathic intervention.)
研究者
Dr Suraia Parveen
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy